PharmacovigilanceOfficial

FDA early alert: Intersurgical pulls 22mm Smoothbore breathing systems over connector detachment risk

🇺🇸 FDA MedWatch · Tue 10 Nov 2026

Too little bonding solvent in manufacture may let soft connectors separate from the tubing, risking loss of ventilation; Intersurgical has told US customers to stop using and quarantine 12 affected product codes.

The US Food and Drug Administration has published an early alert on certain Intersurgical Inc. 22mm Smoothbore breathing tubes and systems, after the company asked customers to remove them from use or sale. The agency classes the matter as a potentially high-risk device issue and says it will update its web page as significant new information emerges.

Intersurgical told the FDA that tetrahydrofuran (THF) solvent is used during manufacture to bond the soft connectors to the Smoothbore tube. Reports of connectors coming away from the tube in markets outside the US prompted an investigation. Testing of internal stock found that some products were made with too little solvent to guarantee a secure connection.

If a connector detaches during use, ventilation may be lost or compromised and the patient may desaturate until ventilation is manually restarted. Depending on the patient, the circumstances and how quickly ventilation is restored, the FDA says this could lead to organ failure, brain damage or death from hypoxia. As of 3 November 2026, Intersurgical had reported no serious injuries or deaths linked to the problem.

The affected products span twelve reference numbers, including heated-wire systems, systems with monitoring lines and exhalation valves, and bilevel systems with a swivel COâ‚‚ leak port, each tied to specific lot numbers. Examples are REF 5018000 (lot 32511811), REF 5025000 (lot 32522651) and REF 5804000 (seven lots). REF 5805030, which includes a Clear-Guard Midi filter, has the longest list, with 18 lots.

Intersurgical wrote to all affected customers on 3 November 2026. It recommends that they immediately stop using and quarantine affected stock, return it to the company, share the notice with all users within their facility, and contact any customers to whom they have distributed the products. US customers with questions or problems can contact Intersurgical Customer Service at recalls@intersurgicalinc.com or 800-828-9633. Adverse events and quality problems can also be reported to FDA MedWatch.

What it means for your team

  • Quality and supply teams at user facilities should match stock against the listed reference and lot numbers, quarantine matches and arrange returns to Intersurgical.
  • Distributors should notify their own customers straight away, as the company's letter asks.
  • Clinical and vigilance staff should report any connector detachment or other adverse event to MedWatch and to Intersurgical.
  • Manufacturers may note that the root cause is a process parameter, the amount of bonding solvent, which was found through post-market reports and internal stock testing.

Official source: FDA MedWatch ↗

Article written by VigiEye from the official source (FDA MedWatch). AI-assisted; check the source before acting.

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